MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EDM LUMBAR CATHETER, CLOSED TIP, BARIUM IMPREGNATED, 80 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	46419
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the device was defective.It was stated the guidewire bifurcation into a filament could not be used.Additional information received reported that the product was broken upon opening the package.
Additional Manufacturer Narrative
The returned device was returned with the catheter, luer connector, blunt needle and strain relief.The guidewire was returned disassembled with a large segment being stretched and knotted.There were kinks in the body of the guidewire.The distal joint of the guidewire was fractured and separated from the core.It is unknown how or when this damage occurred.The instructions for use cautions, ¿improper use of instruments in handling or implanting edm catheter products may result in the cutting, slitting, breakage or crushing of components.¿ proteinaceous debris was observed on the distal joint.No anomalies were found during the review of the device history record.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that there was no product packaging damage upon inspection prior to use.There was no difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.There was no difficulty advancing the devices over the guidewire.The actions that were performed on the guidewire to prepare it for use was removing it form the protective.There were no problems during preparation, and no unusual force required when using the device.

• Brand Name: EDM LUMBAR CATHETER, CLOSED TIP, BARIUM IMPREGNATED, 80 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8621369
• Report Number: 2021898-2019-00185
• Device Sequence Number: 13985833
• Product Code: JXG
• UDI-Device Identifier: 00613994806628
• UDI-Public: 00613994806628
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K862303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 46419
• Device Catalogue Number: 46419
• Device Lot Number: E30581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1